Hugo RAS System— 510(k) K250725

Substantially Equivalent

Covidien, LLC

FDA 510(k) clearance K250725 for Hugo RAS System, Substantially Equivalent on 2025-12-03. Applicant: Covidien, LLC.

Clearance details

Applicant: Covidien, LLC
Product code: Code SCV
Advisory panel: General, Plastic Surgery
Date received: 2025-03-10
Decision date: 2025-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Haven, CT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code SCV

product code SCV

Malfunction: 608
Total: 608

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.